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Podcast: Voices In Validation
Episode:

A Risk-Based Critical Thinking Approach to Computer Systems Validation
Category: Science & Medicine
Duration: 00:57:23
Publish Date: 2021-09-29 14:13:32
Description:

This week, Stacey is joined by Ken Shitamoto to explore critical thinking in the systems validation department and share concepts and case history. Most industry folks have heard about CSA and understand the basics behind the shift in priorities. What’s better left to understand is the if’s and how’s around adoption and implementation within our own organizations. A risk-based approach is nothing new. However, the evolution centers on a risk-based approach using critical thinking, with a focus on assurance needs, testing activities for our higher-risk activities.

About our Guest

Ken Shitamoto, MS

Senor Director, IT, Gilead Sciences

Ken leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 
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